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Diclofenac vs. Placebo in a Randomized Double Blind Controlled Trial in Post ERCP Pancreatitis

NCT01946984 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2013-09-20

No results posted yet for this study

Summary

1. The most common complication of endoscopic retrograde cholangio-pancreaticography (ERCP) is pancreatitis.
2. Several studies showed that non-steroidal anti-inflammatory drugs (NSAIDs) can prevent the post ERCP pancreatitis, the investigators used diclofenac vs placebo.
3. The effect of diclofenac in prevention of that complication, was measured by the number of patients who developed pancreatitis, and compare it with the placebo.
4. The investigators collected 199 patients, 17 excluded, 182 completed the study, all of them underwent the intervention called "ERCP", and randomized to have either Diclofenac or Placebo before the procedure.

Conditions

  • Post-ERCP Acute Pancreatitis.

Interventions

PROCEDURE

ERCP

endoscopy, retrograde cholangio-pancreaticography.

DRUG

Diclofenac hydroxyethylpyrrolidine

DRUG

Normal Saline

Sponsors & Collaborators

  • Specialized Arab Hospital

    lead OTHER

Principal Investigators

  • Yasser Abu-Safieh, MD, AGAF · Specialized Arab Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Palestinian Territories

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01946984 on ClinicalTrials.gov